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Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00488826
Recruitment Status : Completed
First Posted : June 20, 2007
Results First Posted : May 27, 2009
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Pneumococcal Infections
Interventions: Biological: 7-valent pneumococcal conjugate vaccine
Biological: Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited in China from September 2006 to May 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were enrolled into study according to inclusion/exclusion criteria without a screening period.

Reporting Groups
  Description
7vPnC Separately 7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
7vPnC + DTaP Concurrently 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
DTaP Alone DTaP administered at 3, 4, and 5 months of age.

Participant Flow:   Overall Study
    7vPnC Separately   7vPnC + DTaP Concurrently   DTaP Alone
STARTED   300   296   204 
COMPLETED   244   244   178 
NOT COMPLETED   56   52   26 
Withdrawal by Subject                40                35                19 
Protocol Violation                0                0                2 
Adverse Event                9                15                4 
Lost to Follow-up                5                1                0 
Protocol Deviations                2                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
7vPnC Separately 7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
7vPnC + DTaP Concurrently 7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
DTaP Alone DTaP administered at 3, 4, and 5 months of age.
Total Total of all reporting groups

Baseline Measures
   7vPnC Separately   7vPnC + DTaP Concurrently   DTaP Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 300   296   204   800 
Age 
[Units: Months]
Median (Standard Deviation)
 3.5  (1.0)   3.5  (1.0)   3.5  (1.7)   3.5  (1.23) 
Gender 
[Units: Participants]
       
Female   142   133   81   356 
Male   158   163   123   444 


  Outcome Measures

1.  Primary:   Concentration of Serotype-Specific IgG Antibodies   [ Time Frame: 7 months ]

2.  Secondary:   Concentration of Serotype-Specific IgG Antibodies   [ Time Frame: 7 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com



ClinicalTrials.gov Identifier: NCT00488826     History of Changes
Other Study ID Numbers: 0887X-101518
First Submitted: June 18, 2007
First Posted: June 20, 2007
Results First Submitted: March 31, 2009
Results First Posted: May 27, 2009
Last Update Posted: January 20, 2010